SB-0468, As Passed Senate, September 17, 2015

SENATE BILL No. 468

(As amended September 17, 2015)

September 9, 2015, Introduced by Senator GREEN and referred to the Committee on Health Policy.

<<A bill to amend 1978 PA 368, entitled

"Public health code,"

by amending sections 17739a, 17739b, 17739c, and 17748a

(MCL 333.17739a, 333.17739b, 333.17739c, and 333.17748a), sections

17739a, 17739b, 17739c as added by 2014 PA 285 and section 17748a

as added by 2014 PA 280.>>

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

Sec. 17739a. (1) Subject to subsection (2), the department may

license an individual who meets all of the following requirements

as a pharmacy technician under this part:

(a) Submits a completed application to the department on a

form prescribed by the department.

(b) ~~Graduated~~ Except as otherwise provided in subsection (4),

graduated from an accredited high school or comparable school or

educational institution or passed the general educational

development test or other graduate equivalency examination.

(d) Except as otherwise provided in subsection (4), passes and

submits proof to the department of passage of any of the following:

(i) The certified pharmacy technician examination given by the

~~pharmacy technician certification board.~~Pharmacy Technician

Certification Board.

(ii) The certified pharmacy technician examination given by

the ~~national healthcareer association.~~National Healthcareer

Association.

(iii) Any other nationally recognized and administered

certification examination approved by the board.

(iv) An employer-based training program examination that is

approved by the board and covers job descriptions, pharmacy

security, commonly used medical abbreviations, routes of

administration, product selection, final check by pharmacists,

guidelines for the use of pharmacy technicians, pharmacy

terminology, basic drug information, basic calculations, quality

control procedures, state and federal laws and regulations

regarding pharmacy technician duties, pharmacist duties, pharmacy

intern duties, prescription or drug order processing procedures,

drug record-keeping requirements, patient confidentiality, and

pharmacy security and drug storage.

(2) An individual who is not a pharmacist, pharmacist intern,

or pharmacy technician shall not perform any of the functions

described in section 17739(1) for a pharmacy.

(3) A pharmacist shall not allow any individual employed or

otherwise under the personal charge of the pharmacist to violate

subsection (2). A person that owns, manages, operates, or conducts

a pharmacy shall not allow any individual employed or otherwise

under the control of that person to violate subsection (2).

(4) An individual who meets any of the following is not

required to meet the ~~examination requirement described in~~

~~subsection (1)(d)~~ requirements of subsection (1)(b) and (d) to be

eligible for a license under subsection (1):

(a) As provided in section 16171(a), is a student in a

pharmacy technician program approved by the board.

(b) Is applying for a temporary license under section 17739b.

Sec. 17739b. (1) Subject to section 17739a(4), the department

may issue a temporary license as a pharmacy technician to an

individual who is preparing for the examination under section

17739a(1)(d). Notwithstanding section 16181, the term of a

temporary license issued under this section expires ~~210 days~~ 1 year

after the date the temporary license is issued.

(2) An individual requesting a temporary license under this

section shall submit a completed application, on a form prescribed

by the department, to the department and pay the applicable fee

under section 16333.

(3) An individual who holds a temporary license as a pharmacy

technician issued under subsection (1) is subject to all of the

requirements of this part, and rules promulgated by the department

in consultation with the board, applicable to pharmacy technicians

except the examination requirement under section 17739a(1)(d).

Sec. 17739c. (1) In addition to the requirement of section

16182 and subject to section 17739a(4), the department may issue a

limited license as a pharmacy technician to an individual if all of

the following are met:

(a) The individual was employed as a pharmacy technician by a

pharmacy on ~~the effective date of the amendatory act that added~~

~~this section~~ December 22, 2014 and has been continuously employed

by that pharmacy since that date.

(b) The individual submits a completed application to the

department on a form prescribed by the department and meets the

requirements of section 16174.

employment as a pharmacy technician for a minimum of 1,000 hours

during the 2-year period immediately preceding the date of his or

her application under subdivision (b).

(d) The applicable fee under section 16333 is paid.

(2) An Except as otherwise provided in subsection (5), an

individual who holds a limited license under this section may only

act as a pharmacy technician for the pharmacy described in

subsection (1)(a) and only until 1 of the following occurs:

(a) He or she is no longer employed by that pharmacy to

perform those functions.

(b) He or she performs any of those functions for another

pharmacy.

(3) The term of a limited pharmacy technician license issued

by the department under this section is the same as a pharmacy

technician license issued by the department under section 17739a.

(4) An individual who holds a limited pharmacy technician

Senate Bill No. 468 as amended September 16, 2015 (1 of 2)

license issued under this section is subject to all of the

requirements of this part, and the rules promulgated by the

department in consultation with the board, except the examination

requirement under section 17739a(1)(d).

(5) An individual who is employed as a pharmacy technician by

an employer that operates multiple licensed pharmacy locations may

work as a limited license pharmacy technician at any of the

employer's licensed pharmacy locations in this state.

<<Sec. 17748a. (1) Beginning ~~on the effective date of this~~

~~section,~~ September 30, 2014, an applicant for a new pharmacy

license for a pharmacy that will provide compounding services for

sterile pharmaceuticals shall submit verification of current accreditation through a national accrediting organization approved

by the board or verify the pharmacy is in the accreditation

process. The department shall not issue a license to a pharmacy

described in this subsection that is not accredited unless the

applicant demonstrates compliance with USP standards in a manner

determined by the board.

(2) By ~~1 year after the effective date of this section,~~

September 30, 2016, a pharmacy that is licensed on ~~the effective~~

~~date of this section~~ September 30, 2014 and that provides

compounding services for sterile pharmaceuticals must be accredited

by a national accrediting organization approved by the board, be

verified by the board as being in the accreditation process, or be

in compliance with USP standards in a manner determined by the

board.

(3) Notwithstanding any provision of part 161 to the contrary,

a pharmacy that provides compounding services for sterile

pharmaceuticals shall submit with a license renewal application

verification of current accreditation or compliance with USP

standards, as applicable.

(4) A person that provides services consistent with an

outsourcing facility shall comply with requirements of the FDA

applicable to compounding services for sterile pharmaceuticals.

(5) A pharmacy shall notify the department of a complaint

filed by another state in which the pharmacy is licensed for

violations of that state's pharmacy laws, an investigation by

federal authorities regarding violations of federal law, or an

investigation by any agency into violations of accreditation

standards regarding compounding activities within 30 days of

knowledge of the complaint or investigation.

(6) Except for distribution within a hospital or another

health care entity under common control when regulated by federal

law, a pharmacist shall maintain a record of a compounded sterile

pharmaceutical in the same manner and for the same retention period

as prescribed in rules for other prescription records. The

pharmacist shall include, but is not limited to including, all of

the following information in the record required under this

subsection:

(a) The name, strength, quantity, and dosage form of the

compounded pharmaceutical.

(b) The formula to compound that includes mixing instructions,

all ingredients and their quantities, and any additional

information needed to prepare the compounded pharmaceutical.

identification number.

(d) The date of preparation.

(e) The manufacturer and lot number of each ingredient.

(f) The expiration or beyond-use date.

(g) The name of the person who prepared the compounded

pharmaceutical.

(h) The name of the pharmacist who approved the compounded

pharmaceutical.

(7) A pharmacist shall not offer excess compounded

pharmaceuticals to other pharmacies for resale. A compounding

pharmacy shall not distribute samples or complimentary starter

doses of a compounded pharmaceutical to a health professional.

(8) A compounding pharmacy may advertise or otherwise promote

the fact that they provide compounding services.

(9) Based on the existence of a health professional/patient

relationship and the presentation of a valid prescription, or in

anticipation of the receipt of a prescription based on routine,

regularly observed prescription patterns, a pharmacist may compound

for a patient a nonsterile or sterile pharmaceutical that is not

commercially available in the marketplace.

(10) Notwithstanding any provision of this act to the

contrary, a person shall not compound and manufacture drug products

or allow the compounding and manufacturing of drug products at the

same location.

(11) The department, in consultation with the board, may

promulgate rules regarding conditions and facilities for the

compounding of nonsterile and sterile pharmaceuticals.>>